Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078395
Company: RUBICON
Company: RUBICON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE | EQ 2% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/28/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078395s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/03/2021 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/27/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
01/28/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
DORZOLAMIDE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC; EQ 2% BASE
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE | EQ 2% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 212639 | ALEMBIC |
DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE | EQ 2% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 090143 | BAUSCH AND LOMB |
DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE | EQ 2% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 205294 | FDC LTD |
DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE | EQ 2% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 215660 | GLAND PHARMA LTD |
DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE | EQ 2% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 202053 | INDOCO |
DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE | EQ 2% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 204778 | MICRO LABS |
DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE | EQ 2% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 078395 | RUBICON |
DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE | EQ 2% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 078748 | SANDOZ |
DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE | EQ 2% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 078981 | SANDOZ |